Equipment for administering enemas for radiological purposes



United States Patent l1113,543,744

[72] Inventor Edwin LePar 2,457,244 12/1948 Lamson 128/246 542-B-lBellscourt Sal Ha b 2,865,373 12/1958 Recker 128/239 Apartments,Andalusia, P nn l i 2,898,917 8/1959 Wallace..... 128/350 190203,367,338 2/1968 Crandal1.... 128/350 [2]] Appl. No. 779,878 3,459,1758/1969 Miller 128/2 [22] Filed Nov. 29,1968 Primar y Exammer-Rrchard A.Gaudet [45] Patented 1970 AssistantExaminer-Ronald L. Frinks Artorney-Synnestvedt & Lechner 54 E UIPMENT FOR ADMINISTERING ENEMAS FOR I 1RSDIOLOGICAL PURPOSES ABSTRACTt Equipment for administering enemas,particu- 8 Claims 6 Drawing Figs. lajrzly tfoirtgagiologrial pltiirposesand cgfillpl'lljsllg antgbturator a e e osr one ex erna o e o m e re ion[52] US. Cl 128/2, f S imaging} opening, the obznator being fl ibl[28/246, 128/283, l28/3 distendable or inflatable. The equipment furtherincludes an Int. annular sealing element at the inner face of theoburator m ada ted to rovide a 1i uid-ti ht seal between the obturator[50] Field of Search 128/2, 239, andpthe fg f the g in f region aroundthe i t ti l 241, 242, 245. 246, 248, 251, 344, 283, 348-41 opening, andalso a catheter extended through the obturator and the annular sealingelement. Provision is made for moor- [56] References cued ing theobturator in position on the body. The obturator, seal- UNITED STATESPATENTS ing element, and catheter are formed of radiolucent material1,696,763 12/1928 Hare 128/349 and a radio-opaque marker is providedadjacent the entrance 2,212,334 8/1940 Wallerich 128/349X to theintestinal opening.

Patented Dec. 1, 1970 Sheet v or 2 mvm'rnm [BM/V 117 /45 EQUIPMENT FORADMINISTERING. ENEMAS ron nAnioLocicAt runrosss This invention relatesto equipment for introducing fluids, more particularly liquids into bodyopenings, especially intestinal openings, and the equipment isparticularly adapted for administering enemas, such as barium enemas,for radiological purposes.

Although the equipment is adaptable to certain other uses, it isespecially adapted for administering enemas for radiological purposes,and it is therefore hereinafter described and is also illustrated in thedrawings in that association.

A special problem arises in connection with various patients having.colostomies, because of the fact that the colostomy makes no provisionfor the retention of liquids within the intestine. Administering abarium enema through a colostomy is therefore a difficult procedure andhaving in mind that an effective radiological diagnosis depends at leastin part upon the absence of the barium enema liquid on the exteriorsurfaces of the body, the invention makes provision for administeringthe barium liquid and for reliably confining it to the interior of theintestine.

Sometimes similar problems are also encountered with pa tients in whichthe intestinal connection with the rectum is not interrupted by acolostomy. While in some patients the action of the rectal sphincter isadequate to retain a barium enema liquid, this is not true of allpatients, and especially in aged 'and/or senile patients, it isfrequently a difficult procedure to administer a barium enema forreasons similar to those present with a patient having a colostomy.

The present invention has as its primary objective the provision ofequipment which in appropriately modified forms will meet the problemsreferred to above in connection with administering barium enemas eitherto the patient having a colostomy or to a patient having inadequatecontrol of the rectal sphincter.

Although certainequipment has been proposed for use in administeringbarium enemas, such equipment has been subject toa number ofdisadvantages. Thus, in some cases, it was proposed to employ anobturator adapted for inflation internally of the intestinal opening.For this type of device to be effective and provide an adequate sealagainst loss of the enema liquid, it was necessary for the obturator tobe inflated sufficiently to provide a considerable pressure engagementwith the internal wall of the intestine. This is not only uncomfortableto the patient but represents a hazard because a considerable pressurewithin the intestine, especially in certain pathological conditions, canrupture the intestine. Certain prior devices also have been suggested inwhich some portion of the equipment is intended to be applied orat'least retained in position by the hand of the patient. This, however,is also objectionable from the several standpoints including the factthat the bones of the hand are at least in part radio-opaque therebyadversely influencingthe radiological examination, and the further factthat it is undesirable to unnecessarily subject the patients hand to theaction of the radiation employed in the procedure. I

Further objects of the present invention are to overcome thedisadvantages of the prior devices such as those referred to above andto provide equipment which is not only reliable and convenient in usebut which is formed of materials which are radiolucent, so as not tointerfere with the radiologists analysis, whether it be by way of X-raypictures of fluoroscopic examination. It is also an objective of theinvention to ensure that the equipment employed is radiolucentespecially in the region at and adjacent to the entrance to theintestinal opening. This is of especial importance in the form of theequipment adapted for use with a colostomy, because the regionimmediately at and adjacent to the stoma is frequently one of the mostirn'portantto be studied.

Still another object of the invention is to provide equipment of thekind above-described and further including a radioopaque markerpositioned so that when the equipment is in use the marker will lie ator substantially at the entrance of the intestinal opening, therebyassisting the radiologist in distinguishing the areas within theintestine from those outside of the intestine.

How the foregoing and other objects and advantages are attained willappear more fully from the following description referring to theaccompanying drawings illustrating preferred embodiments of theequipment respectively adapted for use with a colostomy and with arectum. In the drawings:

FIG. 1 is a small scale view of the form of the device adapted for usewith a colostomy. This FIG. showing its position in relation to the bodyof a patient. The body being shown in dot and dash lines;

FIG. 2 is a sectional view through the equipment of the invention, alsoshowing portions of the patients body in dotand-dash lines, this viewbeing on an enlarged scale as compared with FIG. 1;

FIG. 3 is a fragmentary view illustrating details of a fastening devicefor mooring the equipment to the body of the patient;

FIG. 4 is a view similar to FIG. 1 but illustrating the form of theequipment adapted for use in administering enemas through the rectum;

FIG. 5 is an enlarged sectional view comparable to FIG. 2, illustratingthe equipment of FIG. 4, this view being taken in a plane transverse tothe gluteal cleft of the patient; and

FIG. 6 is a view of the equipment of FIGS. 4 and 5 as applied to apatient, and illustrating the equipment in elevation in a direction atright angles to the illustration of FIG. 5, this view being on a scaleintermediate the scale of FIGS. 4 and 5.

Referring first to the embodiment illustrated in FIGS. 1 to 3, theequipment includes an obturator 7 adapted to be positioned adjacent anexternal surface of the body of the patient in the region of acolostomy. In FIG. 2 the abdominal wall of the patient is indicated atA, the intestine, usually a part of the colon, being indicated at I, andthe colostomy at C.

The obturator comprises a flexible cell and while this cell might beexpanded by introduction ofa pressure liquid, in the preferredembodiment, the obturator is pneumatically inflatable, preferably beingarranged to be inflated merely by introduction of air in the mannerdescribed herebelow. In the preferred embodiment as illustrated, theobturator is generally -of lenticular shape and is-provided with amooring strap 8 adapted to encircle the body of the patient, forinstance in the region of the lower abdomen. The body encircling strap 8is adaptedto cooperate with fastening strips 9 extended over boththeinner and outer surfaces of the obturator and advantageously securedthereto by some adhesive compound. At

at least one side of the obturator, for instance at the right-hand sideas viewed in FIG. 2, the strap 8 is adapted to be fastened to the strips9 by means of a lug 10 secured to the strips 9 and having a head 11adapted to pass through any one of several tures 12 provides foradjustment of the belt so as to fit the girth of the particular patientbeing examined.

At the opposite side of the obturator, a similar fastening lug 10 may beprovided if desired so that the adjustment may be made at either or bothends of the belt.

The equipment further includes a sealing element and while this elementmay take the form ofa pneumatic sealing ring, a particularly effectivesealing element comprises a piece of sponge rubber such as indicated atI4 in FIG. 2. The sealing element 14 advantageously is provided with asurface layer which, although flexible and resilient,'is impervious soas to avoid absorption of the barium liquid into the sealing element,which would adversely influence the radiological examination. Such animpervious layer may be provided either by appropriate treatment of thesurface layer of the sponge rubber or plastic itself, or may be providedby adhesively applying some impervious sheet material. This sealingelement is desirably of some appreciable diameter, for instanceapproximately half of the diameter of the obturator itself and ispreferably also of some appreciable thickness, thereby providing arelatively large measure of resilience adapted to accommodate theequipment to the contours of the patient's body. The sealing element 14is also desirably annular in order to provide a liquid-tightseal betweenthe obturator and the abdominal wall of the patient in the annularregion surrounding the colostomy.

The enema liquid to be administered is introduced into the intestinethrough the colostomy by means of a catheter generally indicated at Twhich extends through the obturator and the sealing element. The innerend 15a of the catheter extends through the colostomy and well into theintestine when the equipment is applied to the patient, openings 15bbeing provided adjacent the tip of the inner end 15a in order todischarge the enema liquid within the intestine.

The outer end 140 of the catheter is extended for cooperation with asource of supply of the enema liquid for instance the supply canister 16which may be connected with the catheter through'a tube 17 and the tubejoint 18, as illustrated in FIG. 1.

The principal passage through the catheter extends through the obturatorto the inner end and to the tip thereof, as clearly appears in FIG. 2.in addition, the catheter is provided with an auxiliary passage 15a forinflating the obturator. One end of this auxiliary passage opens intothe interior of the obturator as indicated at 15s. The other end of thisauxiliary passage is connected with the lateral branch tube 14f withwhich the hand bulb 19 is connected, a controllable valve 20 beingprovided so that after the obturator has been inflated to the desiredextent the valve 20 may be closed in order to retain the establishedpressure within the obturator.

With respect to the materials employed for the various parts of theequipment, it is preferred to form all of the parts thus far describedof radiolucent materials, i.e., materials which will not cast anyappreciable shadows or markings either in X- ray photographs or upon thescreen used in fluoroscopic examination. Various materials may beutilized for this purpose, including rubbers of various kinds includinglatex rubbers, and also various plastic materials such as polyethyleneand polyvinyl chloride. The materials employed should in general beflexible, particularly the obturator and the catheter, and a relativelyhigh degree of flexibility is desirable at least in the inner endportion of the catheter which is adapted to be inserted through thestoma of the colostomy into the intestine. This is important because thepenetrating end of the catheter should readily follow the contour of theintestine without any appreciable abrasion. Neither the obturator northe catheter need have a high degree of resilience or elasticity. On theother hand it may be advantageous to form the mooring straps of materialhaving notonly flexibility but also elasticity or resilience, so asreadily to conform to the contours of the pa.

tients body, With materials used for those parts in which radiolucenceis important, the materials selected should of course be free of certainpigments, especially inorganic compounds, which would tend to impair thedesired radiolucent characteristic.

To permit repeated use of the equipment, it is contemplated that thematerials used should be capable of withstanding temperatures at theboiling point of water, and preferably somewhat higher, so that theequipment would be autoclavable and thus sterilizable in well-knownmanner.

The sealing element Ml may also be formed of rubber or plasticmaterials, and in the preferred embodiment this element is formed of acellular or foamed material of considerable resilience so as to providean adequate seal against the abdominal wall surrounding the stoma of thecolostomy, even with considerable variation in the angular position ofthe catheter l5 and of the obturator.

In the preferred embodiment, even the lugs All or other equivalentfastening devices are preferably formed of radiolucent materials, sothat, in general, any part of the equipment lying within the line ofradiation will not adversely influence the radiological examinationbeing conducted.-

It is desirable, however, to provide a radio-opaque marker, therebyfacilitating the examination by providing demarcation at the plane ofthe stoma of the colostomy. This is achieved, according to theinvention, by providing a bead of radio opaque material 21 surroundingthe catheter in the plane of the inner face of the sealingelement 14. inthis way, when the equipment is applied to the patient the bead orannulus 21 will lie at the surface of the body surrounding the stoma andthereby clearly demark the limit of the region to be examined. Materialssuitable for the radio-opaque marker are lead, barium or iodidecompound. The particular material is not of special importance, so longas the material has appreciable radio opacity. This marker preferably isof annular shape and preferably is not of great size, in order to avoidobscuring any substantial area of the field to be examined.

Turning now to the embodiment illustrated in H08. 4, 5 and 6, as aboveindicated, this embodiment is adapted for use in the administrationofenemas through the anus, especially in a patient having inadequatecontrol of the rectal sphincter to retain the enema liquid within theintestine.

in general, the equipment shown in H68. 4, 5 and e comprises parts whichcorrespond to and serve the same general functions as the several partsof the device illustrated in FIGS. ll, 2 and 3. However, in thearrangement of H65. 4, 5 and 6, the equipment, and notably theobturator, is specially shaped to fit the topography of the glutealcleft in the region of the anus.

As will be seen in H08. 4;, 5 and 6, the obturator 22 is shaped ingeneral in the form of a somewhat elongated frustum of a cone adapted tofit between the buttocks which are indicated in dot-and-d ash lines at Band to extend inwardly to the base of the gluteal cleft, which isindicated in H6. 6 at This obturator is adapted to be held in place bymeans of three mooring straps, the straps 23-23 being extended somewhatdownwardly and laterally to encircle the legs of the patient in themanner clearly indicated in FIG. 4. These straps desirably havefastening devices of the same kind described above with referenceto-FIG. 2, including fastening lugs which are adjustable to fit the sizeof the patient The third mooring strap, indicated at 24, is extendedupwardly for attachment to the waist encircling belt The belt 25 mayitselfbe provided with adjustable fastening devices of the kind alreadymentioned, and the strap 24 may be provided with adjustable fasteningdevices for securing it to the belt.

Because of the location of the obturator in the gluteal cleft it isdesirable to provide some stiffening for the lateral or sidewalls of theobturator, and thus assure that the mooring straps will functionproperly in retaining the obturator in the desired position. Suchstiffening may be provided in various ways, as by employing a stiffer orthicker material in the obturator sidewall, but in the preferredembodiment, the obturator sidewalls are formed or molded with stays orstiffening ribs 26. These stays may conveniently be formed ofa plasticmaterial, such as nylon or celluloid. Although the stays are ofsufficient thickness to avoid appreciable collapse of the sidewalls, thestays are nevertheless of sufficient transverse flexibility to com formwith the topography of the body.

An annular sealing element 27, advantageously formed of cellular orfoamed rubber or plastic materials as before, is provided at the end ofthe obturator, so as to engage the body in the region surrounding theanus. This sealing element, like the sealing element 14 of the firstembodiment, is also desirably provided with an impervious surface layer27a.

The catheter employed in the embodiment of H68. 4, 5 and 6 may beidentical with that described above in connection with the firstembodiment and it is therefore unnecessary to describe this catheter indetail again. In general it will be noted that the catheter includes amain tube having an inner end portion adapted to enter the intestinethrough the anus, as clearly appears in F168. 5 and 6. The functioningof the catheter including the use of a hand bulb 19 for inflating the Vobturator is the same as that described above.

As in the first embodiment, a radio-opaque annulus or marker 21 isemployed between the sealing element in the region surrounding the anusin order to provide demarcation of the field of examination.

In accordance with the foregoing, provision is made foradministering'enemas for radiological purposes without encountering someof the problems heretofore encountered. The equipment is simple and safeto use, so that it may readily be handled by technicians The equipmentis effective from the standpoint of avoiding undesired discharge ofenema liquid to the abdominal wall or other surfaces of the bodyadjacent to the intestinal opening to which the equipment is applied.This is of importance in order to avoid adverse effects upon theradiological inspection being made.

The construction of the equipment, and especially of the obturator,catheter, sealing element, and mooring straps of radiolucent material,especially when also employing the radio-opaque marker heretoforedescribed, is highly effective in assisting the radiologist ineliminating undesired images while at the same time clearly demarkingthe field to be examined. 1

With the equipment of the invention it is not required to rely upon thepatient to hold any part of the equipment in place, with variousdisadvantages already noted above. Finally, it is to be noted that theequipment provides for effective radiological examination of intestinalopenings all the way to the extremity or entrance of such openings,which is of importance in certain pathological conditions in which theentrance portion is one of he most important regions to be examined.

lclaim:

1. Equipment adapted for use in administering enemas for radiologicalpurposes, comprising a flexible hollow inflatable obturator adapted tobe positioned adjacent an external surface of a patients body, acatheter extended through the obturator with its inner end apertured andadapted to be inserted into an intestinal opening underlying theobturator and with its outer end projecting at the outer side of theobturator to receive the enema liquid to be administered, the obturatorand catheter being radiolucent, means for mooring the obturator andassociated catheter. to the bodyof the patient, controllable means forinflating the obturator, and a radio-opaque marker on the catheter innerend adjacent the inner surface of the obturator for positioning in theregion of the entrance to the intestinal opening when the inner end ofthe catheter is inserted into such an intestinal openings.

2. Equipment as defined in claim 1 and further including a radiolucentand resilient sealing element at the inner surface of the obturatoraround the inner end of the catheter for providing a liquid seal betweenthe obturator and the surface of the body surrounding the intestinalopening.

3. Equipment as defined in claim 2 in which the resilient sealingelement comprises a porous material having an impervious surface layerfor contact with the surface of the body surrounding the intestinalopening.

4. Equipment adapted for use in administering enemas for radiologicalpurposes, comprising a flexible hollow inflatable obturator of generallylenticular shape adapted to be positioned flatwise adjacent an externalsurface of a patients body in the region of an intestinal opening,controllable means for inflating the obturator, a yielding annularsealing element at the inner surface of the obturator for providing aliquid-tight seal between the obturator and the region surrounding theintestinal opening, mooring straps connected with the obturator andextended from opposite edges thereof for holding the obturator and thesealing element against the body in said region, and a catheter extendedthrough the obturator and through the annular sealing element with itsinner end apertured and adaptedto be inserted into the intestinalopening underlying the obturator and with its outer end projecting fromthe obturator to receive enema liquid to be administered.

5. Equipment according to claim 4 in which the obturator,

catheter and mooring straps are formed of radiolucent materi- 6.Equipment according to claim 4 and further including a radio-opaquemarker surrounding the catheter inner end adjacent the inner surface ofsaid sealing element for positioning at a location adapted to mark theentrance to the intestinal opening when the equipment is in use. p

7. Equipment according to claim 6 in which the obturator, catheter andmooring straps are formed of radiolucent materi- 8. Equipment adaptedfor use in administering enemas for radiological purposes, comprising aflexible hollow inflatable obturator shaped generally as a frustoconicalelement cleft in the region of the anus, controllable means forinflating the obturator a yielding annular sealing element at the innersurface of the obturator for providing a liquid-tight seal between theobturator and the region surrounding the anus, mooring straps connectedwith the obturator and extended from opposite sides thereof for holdingthe obturator and the sealing element against the body in said region,and a catheter extended through the obturator and through the annularsealing element with its inner end apertured to be adapted to beinserted into the intestine through the anus and with its outer endprojecting from the obturator to receive enema liquid to beadministered.

UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION patent 3,543,744Dated December 1, 1970 Inventor(s) Edwin I It is certified that errorappears in the above-identified patent and that said Letters Patent arehereby corrected as shown below:

Col 3, Line 19 "14c should read -l5c Col. 5, Line 48, "openings" shouldread --opening-- Col. 6, Line 37, "frustoconical element cleft in theregion the anus" should read -frustoconical elefixent to fit the glxcleft in the region of the anus-- C01. 6, Line 46, "apretured to beadapted" should read "ape tured and adapted--.

slam MD swan H1619?! SEAL) Mlmk mm mm, m m Oomissloner of Patent:

